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Characterization of Metabolic Biomarkers in Varying Subjects

Characterization of Metabolic Biomarkers in Subjects of Varying Age, Gender, Ethnicity, Body Mass Distribution, Dietary Habits, Exercise Habits, Medication Requirements, and Disease State Burden

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01199692
Enrollment
250
Registered
2010-09-13
Start date
2010-08-31
Completion date
2022-12-31
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Brief summary

Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2 Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain elusive. More positively, the identification of a scientific resolution for obesity and T2D in the short-term is not outside the bounds of reality. Because the complexity of metabolic regulation is likely to include already characterized biomarkers, as well as other unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements, and disease states to discover associations and pathways related to the restoration of normal metabolism.

Detailed description

As an observational study design, study investigators will prospectively identify potential subjects from various primary care and/or specialty care clinics in Western New York. Prior to the commencement of any study procedures, subjects will document informed consent and acknowledgement of HIPPA rights. Following approval from their practitioner, subjects may be asked on multiple occasions to complete or undergo any or all of the following types of study procedures: * Medical record review and follow-up * Fasting blood sample (volume limitations stipulated within) * Pre-meal, during meal, and post-meal blood sample (volume limits within) * Short-term and/or long-term dietary intervention (MD approved) * Short-term and/or long-term exercise intervention (MD approved) * Blood glucose log * Food and exercise diaries * Pre- and post-medication blood sampling (neutraceutical or Rx products) * 24-hour urine sampling * Spot urine sampling * Stool microbiologic sampling * Intestinal microbiologic sampling (gastric bypass subjects only)

Interventions

None listed

Sponsors

CPL Associates
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Age =\>18 * Weight =\>110 pounds

Exclusion criteria

* Age \<18 * Weight \<110 pounds * Pregnant * Poor venous access or poor likelihood to adhere with study procedures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026